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Neogene Garners Permission From Dutch Regulators to Begin Phase I Trial of TCR Therapy

NEW YORK – Neogene Therapeutics on Tuesday said the Dutch regulatory authority has granted it permission to conduct a clinical trial for NT-125, an autologous multi-specific T-cell receptor (TCR) therapy, in advanced solid tumors.

The Santa Monica, California-based firm will partner with the Netherlands Cancer Institute to conduct a Phase I trial involving adults with different types of advanced solid tumors.

NT-125 is a single-cell product of engineered T cells that Neogene will design to contain up to five neoantigen-specific TCRs unique to each patient. This will allow "multiple neoantigens presented by HLA class I and HLA class II molecules to be targeted," reduce the chance of antigen escape, and potentially improve responses in patients with hard-to-treat cancers, the company said in a statement.

"This authorization and transition to a clinical-stage company marks a significant milestone for Neogene and reinforces our ambition to make an impact on patients with advanced solid cancers with a novel, fully individualized therapy," Neogene CEO and Cofounder Carsten Linnemann said in a statement. "At this new stage of growth, we remain focused on advancing our unique pipeline of fully individualized and shared neoantigen TCR therapies with the goal of changing the paradigm of solid cancer treatment."